Gas-Chromatographic Packing
FDA 510(k) K801833 · Supelco, Inc.
510(k) numberK801833
Submission
- Device name
- Gas-Chromatographic Packing
- Applicant
- Supelco, Inc.
Walker, MI, US - Received
- August 1, 1980
- Decision date
- August 27, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DJA – Column Supports, Glc
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2250
- Specialty
- Clinical Chemistry
More from Supelco, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K894141 | Liquid Chromatography ColumnsDPM · Traditional | 08/21/1989SE |
| K884403 | Liquid Chromatography Columns Solid Phase Ex. TubeDPM · Traditional | 12/22/1988SE |
| K883615 | Liquid Chromatography Columns 5-7070/71/72/73DJY · Traditional | 12/16/1988SE |
| K881868 | Liquid Chromatography Columns Hisep Column & GuardDPM · Traditional | 08/29/1988SE |
| K881361 | Solid Phase Extraction TubesDJY · Traditional | 08/08/1988SE |
| K880724 | Liquid Chromato. ColumnsDPM · Traditional | 05/27/1988SE |
| K874824 | Capillary Columns for Gas ChromatographyDII · Traditional | 01/21/1988SE |
| K871174 | 4-9295 Barbiturates Test MixDKB · Traditional | 06/11/1987SE |
| K862542 | Capillary Columns for Gas ChromatographyDII · Traditional | 08/04/1986SE |
| K862541 | Liquid Chromatography ColumnsDPM · Traditional | 07/29/1986SE |
Questions and answers
When was Gas-Chromatographic Packing cleared by the FDA?
Gas-Chromatographic Packing (K801833) received a 510(k) decision of Substantially Equivalent on August 27, 1980, 26 days after the submission was received.
What is the product code of K801833?
The FDA product code is DJA – Column Supports, Glc, a Class I (low risk) device regulated under 21 CFR 862.2250.